This is a qualitative in-vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) DNA in males or females. This test is intended as an aid in the diagnosis of MG and TV infections in individuals suspected to have MG or TV infection.
Endocervical swab specimens collected with cobas PCR Media Dual Swab Sample Kit
Vaginal swab specimens collected with either cobas PCR Media Uni Swab Sample Kit or Dual Swab Sample Kit
Male and female urine collected with the cobas PCR Urine Sample Kit
Trichomonas vaginalis only: Cervical specimens collected in PreservCyt Solution
Unacceptable Conditions
Samples visibly contaminated or stored at the wrong temperature
Storage/Transport Temperature
2 - 30oC
Stability (from collection to initiation)
Urine is stable for 24 hours before transfer to Roche Lysis Buffer.
Swabs and urine may be stored for up to 12 months once the specimens have been stabilized in Roche Lysis Buffer.
This test is for the qualitative detection of Mycoplasma genitalium and Trichomonas vaginalis DNA in endocervical swabs, vaginal swabs, and male and female urine specimens. This assay is performed using the FDA-approved COBAS TV/MG Test. Presence of DNA is evidence of presumed infection with this organism. For M. genitalium, further testing may be needed if result is negative but MG infection is strongly suspected.
Collection
Purpose
This is a qualitative in-vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) DNA in males or females. This test is intended as an aid in the diagnosis of MG and TV infections in individuals suspected to have MG or TV infection.
Endocervical swab specimens collected with cobas PCR Media Dual Swab Sample Kit
Vaginal swab specimens collected with either cobas PCR Media Uni Swab Sample Kit or Dual Swab Sample Kit
Male and female urine collected with the cobas PCR Urine Sample Kit
Trichomonas vaginalis only: Cervical specimens collected in PreservCyt Solution
Unacceptable Conditions
Samples visibly contaminated or stored at the wrong temperature
Storage/Transport Temperature
2 - 30oC
Stability (from collection to initiation)
Urine is stable for 24 hours before transfer to Roche Lysis Buffer.
Swabs and urine may be stored for up to 12 months once the specimens have been stabilized in Roche Lysis Buffer.
This test is for the qualitative detection of Mycoplasma genitalium and Trichomonas vaginalis DNA in endocervical swabs, vaginal swabs, and male and female urine specimens. This assay is performed using the FDA-approved COBAS TV/MG Test. Presence of DNA is evidence of presumed infection with this organism. For M. genitalium, further testing may be needed if result is negative but MG infection is strongly suspected.
